Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation

NCT03994497 | Recruiting

• 1 other identifier: 49RC18_0018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. Despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival. Different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (HLA) incompatibilities between the donor and the recipient. However, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies. Also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation. The onset of acute rejection is caused by the ability of the recipient's T cells to recognize alloantigens. The CD45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the T cell. Investigators showed that the level of expression of CD45RC on T lymphocytes was associated with the risk of acute rejection. Thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating CD8 lymphocytes expressing high CD45RC (CD45RChigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of CD8+CD45RChigh. The purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy

  12 months

Secondary Outcomes (6)

• Rate of CD45RC for patient with acute rejection suspicion

  12 months

• Rate of CD45RC on circulating T lymphocytes

  from date of randomization until the date of acute rejection, up to 12 months

• Rate of CD45RC on circulating T lymphocytes the day of acute rejection

  12 months

• Rate of CD4, CD8, CD45RA, CD25, CD127, CD19 markers on T cells the day of acute rejection

  12 months

• anti-HLA antibodies' dosage at the time of acute rejection

  12 months

Study Arms (1)

Patient in need of a kidney transplant

OTHER

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples the day of the surgery and 4 times during the next year. Blood samples and histological slides taken at each biopsy and if there is suspicion of rejection of the graft

Patient in need of a kidney transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 and under 70 years old
• Patients in care for a first priority renal transplant.
• Patients with low immunological risk
• Patients with prior written informed consent

You may not qualify if:

• Poor understanding of the French language
• Pregnant, breastfeeding or partying women
• Persons deprived of liberty by an administrative or judicial decision
• Persons undergoing psychiatric care under duress
• Adults who are subject to a legal or non-state protection measure to express their consent

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Dr Anne-Sophie GARNIER

Angers, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Anne-Sophie GARNIER, MD

CONTACT

0241356075; AnneSophie.Garnier@chu-angers.fr

Béatrice GABLE

CONTACT

begable@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 21, 2019
• Study Start: February 3, 2021
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

FR (1)